Those whose symptoms have not responded to other therapies. Those who have advanced and/or progressive neuroendocrine tumors despite somatostatin analogues and are not a candidate for surgery. gallium-68 PET/CT or NETSPOT, gallium-68 PET/MRI or octreotide scan) showing that there are somatostatin receptors present on your tumor cells. You must have a recent somatostatin imaging scan (i.e. This includes NET in the pancreas or GI tract (stomach, intestines, colon, rectum, appendix). *Note: There are many other “keys” in development, which means hope for future options in NET treatment.Īccording to the FDA Approval found here, PRRT is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.Īdults (who are not pregnant) with gastorenteropancreatic neuroendocrine tumors. SSTR therapy is another term for PRRT since it targets the somatostatin receptors. Lutathera® is the first in the class of PRRT drugs currently approved by the FDA and available for use in the United States. Lutathera® is the brand name of radioactive drug or radiopharmaceutical, lutetium-177 (Lu-177) dotatate that is manufactured by Advanced Accelerator Applications (AAA). Lu177 is linked to a protein, forming Lutetium-177 dotatate, to target the same receptors as Ga-68, lanreotide, and octreotide. Lutetium-177 (Lu-177) is a radioisotope used for targeted therapy. There are other types of PRRT currently being developed that may be available only under clinical trials or in Europe.
PRRT is a class of radioactive drugs that uses a targeting molecule bound to a radiation component. NET patients in the United States may see these terms used interchangeably: PRRT Lutetium 177 Dotatate Lu-177 Lutathera® (the brand name for the FDA approved drug) SSTR Therapy What is the difference between PRRT, Lu-177 and Lutathera®? This article will answer more frequently asked questions and provide links to helpful videos, articles, and patient resources. In our previous article, “ These Four Letters: PRRT, An Overview of PRRT”, we gave an overview on PRRT including a discussion of theranostics and the importance of the Ga-68 scan in determining if a patient is a candidate for PRRT. Reposted on April 7th, 2021 More about PRRT Peptide Receptor Radionuclide Therapy
We believe that the use of NETSPOT should also offer increased comfort for patients by potentially shortening a procedure that is currently performed over 24 hours or more to just a few hours.Original Post Written by Lisa Yen, NP, NBC-HWC - April 24, 2019 “NETSPOT has the potential to significantly improve the accuracy of NET diagnosis, while reducing radiation exposure for patients. “The FDA approval of NETSPOT is a key milestone in our mission of improving the lives of NET patients,” said Stefano Buono, Chief Executive Officer of AAA.
#NETSPOT AAA GENERATOR#
NETSPOT is currently approved for use with the GalliaPharm Ga 68 generator from Eckert & Ziegler. AAA intends to commercialize the product in the US in two forms: As a kit for reconstitution using a Ga 68 generator, and as NETSPOT Injection, a ready-to-use dose delivered from a local radiopharmacy in selected metropolitan areas. Gallium Ga 68 dotatate received Orphan Drug Designation from both the FDA and European Medicines Agency (EMA) in March 2014.įollowing today’s approval, NETSPOT will be made available to the US market as soon as possible. NETSPOT is the first approved drug using Ga 68 as a positron emitter. NETSPOT is the new market name for Somakit-TATE (a kit for the preparation of gallium Ga 68 dotatate injection) in the US. NETSPOT received approval following a Priority Review from the FDA. AAA today announced that the US Food and Drug Administration (FDA) has approved NETSPOT(TM) (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
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